[Summary text]
Allocation: randomised - computer generated random list.
Blindness: assessor blind.
Duration: 9 months, with follow up at 12 and 18 months.
Setting: Tameside and Glossop, Stockport and Oldham, England
Diagnosis: comorbid schizophrenia and substance use disorders (ICD 10 and DSM IV)
.
N = 36.
Age: range 17-62 years, mean 30.5.
Sex: 33 M, 3 F.
History: median duration 4 years, range 1-19 years, informed consent obtained
1. Motivational interviewing, cognitive behavioural intervention and family intervention,
using individual and combined sessions, in addition to standard care. N = 18
2. Standard care. N = 18.
Family intervention consisted of 10-16 sessions and the individual interventions (CBT
and motivational intervention) occurred on ~ 29 sessions
Death.
Global state: GAF.
Mental state: PANSS.
Social functioning: SFS.
Relapse.
Unable to use -
Addiction Severity Index: no usable data.
The Drugs Attitude Inventory: no usable data.
The Leeds Dependence Questionnaire: no usable data.
The Alcohol Use Scale: no usable data.
Drug Use Scale of the Clinician Rating Scale: no usable data
Allocation: randomised (by a staffmember who drew names froma canister and, without
looking at the names).
Blindness: single (Independent researcherswhowere blind to study condition, conducted
the assessments).
Duration: 12 months with 18-month follow up.
Setting: Australia.
Diagnosis: schizophrenia (DSM IV).
N = 59*.
Age: mean 34.
Sex: 15 M, F 35.
History: 21 had received hospital treatment before study entry; ten participants had a
substance disorder.
Inclusion criteria: who had a diagnosis of schizophrenia, schizoaffective disorder, or
schizophreniform disorder; who were aged between 18 and 55 years; and who had a
minimum of 10 hours of contact with family members each week
1. Family intervention therapy plus case management. N = 30.
2. Case management. N = 29.
Leaving the study early.
Mental state: BPRS, SANS.
QoL.
Social functioning: HoNOS.
Family outcome: Family Burden Scale.
*Nine participants completed the data collection procedure after treatment
Family intervention - 26 sessions over 12 months
Study design:
Study grouping:
Open Label:
Cluster RCT:
Baseline Characteristics
Familyintervention
TAU
Included criteria: diagnosis of schizophrenia or disorders from the schizophrenicspectrum (delusional disorder, schizophreniformdisorder, schizoaffective disorder, schizoid and schizotyp18 and 65 years of age. Theywere required to have lived in the family of origin for at least 6months, and had face to face contact of at least 35 h a week withthe relatives concerned.patientswere required to be taking an atypical neuroleptic, regardless ofany other medication prescribed.
Excluded criteria: presence of an organic disorder underlying the psychiatric condition or an IQ lower than 75.
Intervention Characteristics
Familyintervention
TAU
Continuous:
Dichotomous:
Sponsorship source: Not stated
Country: Italy
Setting:
Comments:
Authors name: Cinzia Bressi
Institution: Psychiatric Clinic, Milan State University
Email: cinzia.bressi@unimi.it
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Dichotomous outcomes:
Jesper ØStrup Rasmussen End of treatment, and 12 mo after end of treatment. relapse defined as:the transition from a nonschizophrenic state to a schizophrenicstate, with the appearance of specific symptoms evaluatedon a standardized scale (PSE), or the marked re-exacerbationof a symptom already present at t0.Days at hospital not reported, but readmissions reported.
Adverse outcomes:
Allocation: ’randomly assigned’.
Blindness: not blind.
Duration: 10 weeks family therapy, follow up 1 year.
Setting: Italy.
Diagnosis: schizophrenia (DSM-III).
N = 99.
Age: range 18-48 years, mean 27.
Sex: 72 M, 27 F.
History: > 2 episodes or clinically deteriorating, mean previous episodes 2.6, mean
duration ill 5.5 years.
Exclusions: psychiatric secondary diagnoses.
1. Therapeutic relative groups: psychoeducational training, problem solving + relatives
self-help groups, self-supporting after 6 months, 1 session/2 weeks for 1 year. N = 67
2. Standard care. N = 32.
Death.
Relapse.
Hospital admission.
Unemployed.
Independent living.
Unable to use -
Mental state: AMDP (no usable data).
Global state: CGI, GAS (no usable data).
Hospitalisation: no usable data.
Length of admission: no data reported.
Additional medication: no usable data.
Family experience: CFI, FKI, MFB (no usable data).
The therapeutic relative groups and self help groups are added in this review
Allocation: randomised using random number table.
Blindness: ’both relatives and clinicians in the IG groups programme were blind as to
successive participation to the SG’.
Duration 2 years.
Setting: Italy.
Diagnosis: schizophrenia.
N = 101.
Age: mean 29 years.
Sex: 73 M, 28 F.
History: clinically stable.
Inclusion criteria: relatives living with someone suffering from schizophrenia and had
not attended family groups or other support services before the study intervention; the
patient was clinically stable (having had no psychiatric hospitalisation or any relapse for
six months prior to study entry) and was not receiving any psychosocial or rehabilitative
treatment other than standard care; absence of alcohol or drug dependence or organic
disease
1. Family support programme. N = 26.
2. Information group. N = 50.
3. Treatment as usual. N = 25.
All groups received standard antipsychotic care.
Relapse.
Hospitalisation.
Compliance with standard community care.
Objective burden: self-sufficiency, social functioning, worsened.
Relatives’ EE was evaluated by the CFI.
The family support programme is consists of two components that roughly correspond
to the phases of the
group. The first phase involves training on communication and coping skills, stress identification
and management, and multiple family group-based problem solving, basically derived from the second stage of the psychoeducational multiple family group approach
used by McFarlane
Weekly sessions composed of 16-18 relatives for 24 sessions (1.75 h per session) and
leaflets. The second element comprises weekly meetings for 48 sessions (1.5 h
per session) over 2 yearswith a support groupmade up of 8-9 relativeswho have previously
attended the information group
Allocation: randomised, computer generated numbers.
Blindness: not reported.
Duration: 3 months.
Setting: Hong Kong, China.
Diagnosis: schizophrenia (DSM IV).
N = 48.
Age: range 20-50+ years, mean 40.
Sex: 27 M, 21 F.
History: illness less than 3 years, with no comorbidity or other mental illness
1. Mutual family support: twelve, 2-hour group sessions per week, co-facilitated by a
psychiatric nurse. Mutual support included: sharing personal data, fostering dialectical
processes, encouraging discussion of taboo areas, fostering a sense of ’all being in the
same boat’, encouraging mutual support, providing opportunities of individual problem solving and standard care. N = 24.
2. Standard care. N = 24.
Standard care, mostly chlorpromazine, haloperidol (88% in the experimental group and
85% in the control group), with > 70% taking the medium dose
Leaving the study early.
Global state: hospital admission.
Family outcome: family Burden Interview Schedule.
Family outcome: family Assessment Device.
Family outcome: family Support Service Index..
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Familyintervention
TAU
Included criteria: All the families that met the following inclusioncriteria were invited to participate:a. Families living with and caring for one relative with aprimary diagnosis of schizophrenia, according to criteriaof the Diagnostic and Statistical Manual of MentalDisorders, 4th edition, DSM-IV [38];b. The relative with schizophrenia did not suffer comorbidityof other mental illness during recruitmentto the study and who had been diagnosed withschizophrenia for three years or less; andc. Those were aged 18 years or over and able to understandand read the Chinese language.
Excluded criteria: Exclusion criteria included those who cared for morethan one family member with mental illness, who themselveshad mental illness, and who were the primary carers for lessthan three months.
Intervention Characteristics
Familyintervention
TAU
Continuous:
Dichotomous:
Sponsorship source: this study was funded by the Deparmental grant of theNethersole School of Nursing, CUHK
Country: Hong-Kong China
Setting: Outpatient clinic
Comments:
Authors name: Wai Tong Chien
Institution: The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong SAR, P.R. China
Email: wtchien@cuhk.edu.hk
Address: the Nethersole School of Nursing,7/F., Esther Lee Building, Chung Chi College, The Chinese University ofHong Kong, Shatin, N.T., Hong Kong SAR, P.R. China
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Dichotomous outcomes:
Elisabeth Ginnerup-Nielsen Readmissions er opgivet i continous outcomes som en mean af hele gruppen ved hver assessment
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Familyintervention
TAU
Included criteria: Caregivers were eligiblefor the study if they were 18years or older, if they were the maincaregiver for the relative with schizophrenia,and if they lived with the relativewith schizophrenia. Patients hadto be diagnosed as having schizophrenia according to DSM-IV criteria andbe 18 years or older.
Excluded criteria: Caregivers whohad mental illness themselves orcared for more than one relative withmental illness were excluded.
Intervention Characteristics
Familyintervention
TAU
Continuous:
Dichotomous:
Sponsorship source: This research was supported by departmentalresearch grant 2006-07 from the School ofNursing at the Chinese University of HongKong.
Country: Hog Kong
Setting:
Comments:
Authors name: Wai Tong Chien
Institution: School of Nursing, Faculty of Health and Social Sciences, Hong Kong Polytechnic University,
Email: hschien@inet.polyu.edu.hk
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Jesper ØStrup Rasmussen There were no significantsociodemographic or clinical differencesbetween the two studygroups and the 408 persons who didnot participate in the study.
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen FU: 15 mdr. scalessymptoms: BPRS (higher=better)Functioning: SLOF (Specific Level of Functioning scale; possible scores range from 43 to 215, with higher scores indicating better functioning.)days at hospital last 6 mo.carer satisfaction: SSQ6 (The items are rated on a six-point Likert scale, with a higher total score (ranging from 0 to 6) indicating more satisfactionwith the available social support.)
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Familyintervention
TAU
Included criteria: The inclusion criteria of family caregivers and patientswith schizophrenia were those who were: (a) aged 18years or above, speaking in Mandarin/Cantonese; (b) one ofthe main carers who lived with and provided most of thecare for their relative who had a primary diagnosis ofschizophrenia according to the criteria in the Diagnosticand Statistical Manual, DSM-IV (American PsychiatricAssociation, 1994); and (c) patients who did not haveany co-morbidities in terms of other mental disorders atbaseline.
Excluded criteria: Exclusion criteria included those caregivers whothemselves suffered from mental illness or who had beenthe primary carers for less than three months; and thosepatients who were mentally unstable or who had been rehospitalisedbefore the random assignment of the participantsinto study groups.
Intervention Characteristics
Familyintervention
TAU
Continuous:
Dichotomous:
Sponsorship source: Health Care and Promotion Fund, Food andHealth Bureau, The HKSAR Government supported theresearch and governed the progress and review of theresearch.
Country: Hong-Kong China
Setting:
Comments:
Authors name: Wai Tong Chien
Institution: School of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong Special Administrative Region
Email: wai.tong.chien@polyu.edu.hk
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Elisabeth Ginnerup-Nielsen
Jesper ØStrup Rasmussen Time 1=end of treatment, Time 2=længtse FU (24 mdr).skalaer:Socialfunktion: SLOF - socialfunktion subscale (higher=better)Pårørendetilfredshed: SSQ6 (higher=better)
Dichotomous outcomes:
Elisabeth Ginnerup-Nielsen Note fjernet igen
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Familyintervention
TAU
Included criteria: Inclusion criteria were caregiversliving with and caring for a relativewith a primary diagnosis of schizophreniathat met DSM-IV criteria,patients with no other mental illnessat baseline, age .17 years, and understandingof Mandarin or Cantonese
Excluded criteria: Exclusion criteria included caregiverswho had mental illness themselves(N=58) or who had been primarycaregivers for less than three months
Intervention Characteristics
Familyintervention
TAU
Continuous:
Dichotomous:
Sponsorship source: This study was supported by grant 216020 fromthe Health Care and Promotion Fund, HospitalAuthority Hong Kong S.A.R.
Country: China
Setting:
Comments:
Authors name: Wai Tong Chien
Institution: the School of Nursing and the Faculty of Health and Social Sciences, PQ402, Hong Kong Polytechnic University
Email: wai.tong.chien@polyu.edu.hk
Address: the School of Nursing and the Faculty of Health and SocialSciences, PQ402, Hong Kong Polytechnic University, Hung Hom, Kowloon
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Elisabeth Ginnerup-Nielsen SLOF overall tastet i skemaSLOF social functioning subscale: end of treatment mean (sd) Intervention group: 44.80 (15.8) N=35Control group: 38 (10.1) N=36Longest FUintervention: 53.70 (18.90) N=35control: 40.50 (7.50) N=36
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Familyintervention
TAU
Included criteria: Participants were recruited by approaching consecutive patientswho had recently relapsed, whether or not they had beenadmitted. After this index relapse, patients were screened andinvited to take part as soon as they were thought able to giveinformed consent. The inclusion criteria were:(a) a current clinical diagnosis of non-affective psychosis (ICD–10category F2 and DSM–IV);(b) age 18–65 years;(c) a second or subsequent psychotic episode starting not morethan 3 months before they agreed to enter the trial;(d) a rating of at least 4 (moderate severity) for at least onepositive symptom on the Positive and Negative SyndromeScale (PANSS)
Excluded criteria: Criteria for exclusion from the trial were:(a) a primary diagnosis of alcohol or substance dependency,organic syndrome or intellectual disability;(b) a command of spoken English inadequate for engaging inpsychological therapy;(c) unstable residential arrangements such that the likelihood ofbeing available for the duration of the trial was low.
Intervention Characteristics
Familyintervention
TAU
Continuous:
Dichotomous:
Sponsorship source: The study was supported by a Wellcome Trust Programme Grant
Country: UK
Setting:
Comments:
Authors name: Philippa A. Garety
Institution: Department of Psychology, Institute of Psychiatry
Email: p.garety@iop.kcl.ac.uk
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Scales:Symptoms: PANSS (Low=better)Social functioning (high=better)
Elisabeth Ginnerup-Nielsen Social and occupational functioning is rated on a scale of0–100 by the assessor using the Social and Occupational FunctioningAssessment Scale (SOFAS). Higher scores = better adaptive functioning
Dichotomous outcomes:
Jesper ØStrup Rasmussen Definition of relapse: Remission and relapse ratings were made using a publishedmethod employed in a previous randomised controlled trial.1,24Consensus ratings are made by paired members of the researchteam using manualised a priori operationalised definitions, amethod with moderate to good reliability (kappa values of 0.56and 0.71 for the identification of remission and relapse respectivelybetween paired raters) and good validity (independentPANSS ratings were strongly related to the remission/relapseratings of participants).24 Ratings are based on changes in positivepsychotic symptoms. Evidence is required of improvement in (forpartial remission) or absence of (for full remission) positivepsychotic symptoms continuing for at least 4 weeks. Relapseratings are based on evidence of the re-emergence of, or significantdeterioration in, positive psychotic symptoms of at least moderatedegree persisting for at least 2 weeks.Only by 24 mo. Relapse in those with partial or full remission from initial episode.
Elisabeth Ginnerup-Nielsen Er lidt i tvivl om hvornår dette outcome er rapporteret.. Umiddelbart virker det som om tabel 1 rapporterer ved 12 mdr??
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Familyintervention
TAU
Included criteria: (i) schizophreniaor schizophreniform disorder according toDSM-IV criteria (APA, 1994); (ii) to select patients withsevere and persistent disorder but with sufficientstability to allow for establishing a reliable baseline,the following operative criteria were applied: persistingpositive psychotic symptoms for more than 1 yearor a clinical relapse in the previous 2 years, with atleast 2 months of clinical stability, defined as no variationsin two Psychiatric Assessment Scale (PAS) ratingstaken at an interval of 1 month. Patients with suchsevere persistent symptoms that it was not possible toidentify a clinical relapse on the PAS were excluded;(iii) aged 17–55 years; (iv) having lived at home formore than 1 month with a key relative (identified asthe relative with the greatest number of hours of faceto-face contact with the patient) with a critical attitude,measured by means of the Semantic Differential (atleast one item with a positive score under the dimensionof negative evaluation or passivity), or a deficit inempathic capacity (index of empathic capacity o0.5)measured using the Empathy Questionnaire (GiroŽn & GoŽmez-Beneyto, 1995, 2004); (v) absence of mentalretardation, serious cognitive disorder, abuse or dependenceon toxic substances according to the DSMIVcriteria in the patient and their relative, includingserious mental illness in the latter ; and (vi) familygroup or key relative had not received psychoeducationalfamily intervention lasting for more than3 months.
Excluded criteria:
Intervention Characteristics
Familyintervention
TAU
Continuous:
Dichotomous:
Sponsorship source: This study was supported by project grant 97/1159from Fondo de Investigaciones Sanitarias, and projectgrant 011010 from FundacioŽ La MaratoŽ de TV3. Thisstudy was supported by the AssociacioŽ Valencianade Doce`ncia i InvestigacioŽ en Salut Mental.
Country: Spain
Setting:
Comments:
Authors name: M. Giron
Institution: Department of Clinical Medicine, University Miguel HernaŽndez, Alacant, Spain
Email: giron@icali.es
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Elisabeth Ginnerup-Nielsen Family burden was evaluated by means of theSpanish version of the Social Behaviour AssessmentSchedule (SBAS; Plattet al. 1980; GoŽmez-Beneyto et al.1986).(the sum ofthe key relative’s rating of the level of objective difficultiesin eight areas of his/her life when these are notconsidered in relation to the presence of the patient athome was also used)(the higher the score, the moreburden perceived)
Jesper ØStrup Rasmussen Interventionperiod: 24 mo. Scales:clinical relapse definition: To establish clinical relapse, the method of Vaughn et al. (1984) was followed. Persisting positive symptoms were definedaccording to criteria described previously (GiroŽn &GoŽmez-Beneyto, 1995, 2004).Burden: SBAS (Low=better)
Jesper ØStrup Rasmussen Length if intervention: 24 mo, no FU. Clinical relapse definition: To establish clinical relapse, the method of Vaughn et al. (1984) was followed. Persisting positive symptoms were definedaccording to criteria described previously (GiroŽn & GoŽmez-Beneyto, 1995, 2004).Family burden: SBAS (low=better)
Dichotomous outcomes:
Adverse outcomes:
Allocation: randomised, stratified by premorbid psychosocial competence, sex - no further
details.
Blindness: single - definition of relapse + BPRS, single and non-blind - decision to rehospitalise.
Duration: 6 weeks treatment, 6 months follow up.
Setting: Ventura, USA.
Design: factorial.
Diagnosis: schizophrenia (New Haven Index > 4).
N = 104*.
Age: mean 23.4 years.
Sex: 57 M, 47 F.
History: ’acute’, consecutive admissions, 1-2 previous admissions
1. Crisis-orientated family therapy: 1 session/week, 6 weeks + standard care, varied
treatment thereafter. N=52
2. No family therapy: standard care, varied treatment after 6 weeks. N = 52
Factored with:
A. High dose fluphenazine.
B. Low dose fluphenazine.
Relapse (full-time admission, partial hospitalisation or substantial change inmedication)
.
Leaving the study early.
Unable to use:
Mental state: BPRS (subgroup analysis, no SD).
Suicide: N = 2, original allocation unclear.
Service use: no usable data.
* total N is 103 in second paper - reasons unclear.
Data relating to high and low dose fluphenazine not used in this review.
Leaving the study early data is contradictory in different parts of report - first set of data
chosen at random
Allocation: randomised.
Blindness: not blind.
Duration: 3 years treatment, 3 years follow up.
Setting: Pittsburgh, USA.
Design: factorial.
Diagnosis: schizophrenia + schizo-affective disorders (RDC).
N = 97.
Age: range 16-55 years, mean 28.6.
Sex: 56 M, 41 F.
History: acute admissions, mean previous admissions 2.7, mean length of illness 6.2
years.
Exclusions: organic brain syndrome, drug or alcohol dependence in past 6 months,
medical conditions preventing use of antipsychotic medication
1. Personal therapy: psychoeducation, relaxation, identification of stressors and prodromal
symptoms, social skills training + neuroleptic medication. N = 23
2. Supportive therapy: active listening, empathy and reassurance, advocacy and problem
solving + neuroleptic medication. N = 24
3. Family therapy: joining, survival skills training, reintegration into the family and the
community + neuroleptic medication. N = 24
4. Personal therapy + family therapy. N = 26.
All groups received more than 5 sessions.
Relapse (psychotic).
Leaving the study early.
Unable to use:
Drug compliance: no usable data.
Therapeutic alliance: no usable data.
The paper reports two trials (N = 151), one studying patients who lived with families
(N = 97) and one studying patients who lived alone. This review only looked at the data
from the former trial.
For this review supportive therapy is the control arm and family therapy is the intervention
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Familyintervention
TAU
Included criteria: 1. They were living with and caring for one child with a primary diagnosis of schizophrenia, according to criteria of the DSM-IV (American Psychiatric Association, 1994).2. They were aged 45–65 years.3. They were able to read and write Persian.4. They had the same social-economic status (SES).5. They were resident in the middle-class city of Tehran.6. They had completed a consent-to-participate letter.7. Their schizophrenic child had no other mental illness, and the duration of schizophrenia was three years or less at the time of recruitment.
Excluded criteria: 1. They had a diagnosis of mental illness.2. They cared for more than one family member with chronic physical or mental illness.3. They had been the primary carer for fewer than three months.
Intervention Characteristics
Familyintervention
TAU
Continuous:
Dichotomous:
Sponsorship source: Not stated.
Country: Iran
Setting:
Comments:
Authors name: Anahita Khodabakhshi Koolaee
Institution: Faculty of Counselling and Family, Department of Family Counselling, Social Welfare & Rehabilitation University, Tehran, Iran.
Email: anna_khodabakhshi@yahoo.com
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Jesper ØStrup Rasmussen Only for the total sample.
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Length of intervention: 3 mo. (measurement at baseline (T1), after three months (T2) and after six months (T3)) The FU is then 3 mo, our cutoff is 4 mo. Scales:Burden: FBIS (low=better)
Dichotomous outcomes:
Adverse outcomes:
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Familyintervention
TAU
Included criteria: a diagnosis of schizophreniaaccording to the Diagnostic and StatisticalManual (28), based on a structuredinterview, a duration of illness of 2–10 yearsand were living with a relative continuously for aperiod of 2 years or more prior to inclusion inthe study.
Excluded criteria: Patients with comorbid axis I psychiatricdisorders, personality disorders, substanceabuse or dependence (except nicotine), organicbrain syndrome or mental retardation wereexcluded.
Intervention Characteristics
Familyintervention
TAU
Continuous:
Dichotomous:
Sponsorship source: This study was funded by the WHO-SEARO, India
Country: India
Setting: outpatients
Comments:
Authors name: Kulhara P,
Institution: Department of Psychiatry, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India
Email: param_kulhara@yahoo.co.in
Address: Department of Psychiatry, PGIMER,Chandigarh-160012, India.
Identification:
Participants:
Study design:
Baseline characteristics:
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Scales:Carer satisfaction: Satisfaction with treatment among caregivers was rated using the Patient Satisfaction Questionnaire (33), slightly modified for use among caregivers. This four-item scale with scores ranging from 0 to 12 has been found to be a valid index of quality of care in a psychiatric service.Family burden: Burden on caregivers was assessed using the Family Burden Interview Schedule, FBIS (Low=better)resultat: F = 1.74; df = 1, 74; P > 0.05Relapse definition: Relapse was defined as either the presence of psychotic symptoms (delusions, hallucinations, gross-behavioural disturbances)for 2 weeks or more, or re-hospitalisation.
Elisabeth Ginnerup-Nielsen Carer satisfaction assessed via: Patient Satisfaction Questionnaire modified for use among caregivers. higher scoresindicate greater satisfaction with the aspect of careFamily burden assessed with F values? Probably not usable
Dichotomous outcomes:
Adverse outcomes:
Allocation: block randomisation.
Blindness: single.
Duration: follow up 1 year.
Setting: Aarhus, Denmark.
Diagnosis: schizophrenia (ICD-10).
N = 46.
Age: range 30.3 - 39.6 years, mean 35.9.
Sex: 24 M, 22 F.
History: receiving treatment at time of inclusion in community psychiatric centres
1. Eight-intervention session using mainly a didactic interactive method with the patient
and care interventions performed in separate sessions. N = 23
2. Standard care with psychosocial rehabilitation and supportive psychotherapy. N = 23
Relapse.
Leaving the study early.
Global state: GAF.
Mental state: BPRS, IS.
Service satisfaction: VSSS.
Knowledge of schizophrenia.
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Familyintervention
TAU
Included criteria: family caregivers of patientswith schizophrenia
Excluded criteria:
Intervention Characteristics
Familyintervention
TAU
Continuous:
Dichotomous:
Sponsorship source: Behavioral Sciences Research Center provided the research grant for this study.
Country: Iran
Setting:
Comments:
Authors name: Ali Navidian
Institution: Department of Mental Health & Psychiatric Nursing, Pregnancy Health Research Center, Zahedan University of Medical Sciences, Zahedan, Iran
Email: alinavidian@gmail.com
Address:
Identification:
Participants:
Study design:
Baseline characteristics:
Elisabeth Ginnerup-Nielsen percentage of males in both groups: 58
Jesper ØStrup Rasmussen 50% of the patients had schizophrenia, and 50% mood disoirders. The characteristics are for the total sample, but the results are presented for each condition.
Intervention characteristics:
Pretreatment:
Continuous outcomes:
Jesper ØStrup Rasmussen Results only for the sample with schizophrenia. Lengst of intervention: 3 mo, FU period is 3 month, our cutoff is 4 mo. Scales:family burden: ZBI (The items are answered on a five-point scale ranging from 0 (never) to 4 (always). Scores were calculated by summing up the total chosen statement whichranges from 0 to 88, that higher scores implying greater perceived caregiver burden.)
Dichotomous outcomes:
Adverse outcomes:
Allocation: randomised.
Blindness: open study.
Duration: three years.
Setting: China.
Diagnosis: chronic schizophrenia (CCMD-3, ICD-10).
N = 150.
Age: 18-55 years.
Sex: men and women.
History: no details.
1. Family intervention: 1.5 hour/session, once a month. N = 75.
2. Medication. N = 75.
Relapse.
Social functioning: Social Disability Screening Schedule
Allocation: ’randomly allocated’ - method not described, stratified by first/multiple
episode, presence/absence of residual symptoms and EE.
Blindness: single - CFI, PSE, relapse.
Duration: 9 months treatment, 8 years follow up.
Setting: Salford, UK.
Diagnosis: schizophrenia (PSE).
N = 83*.
Age: range 16-64 years, mean 35.3.
Sex: 29 M, 54 F.
History: acutely ill, hospital admissions, to be discharged to family having lived with
them > 3 months, mean past admissions ~ 3, mean duration ill ~ 6 yrs.
Excluded: organic illness.
1. Enactive programme: active participation of families including role play. N = 16
2. Symbolic programme: advice and verbal instructions to families. N = 16
Education only: 2 sessions with family. N = 16* high EE, 9 low EE.
Control: routine multidisciplinary care in OPD. N = 16* high EE, 10 low EE
More than 5 sessions.
Death.
Relapse (recurrence/worsening of psychotic symptoms over 1 week, PSE).
Hospital admission.
Leaving the study early.
Family experience: CFI.
Unable to use:
Contact with services: no data.
Use of medication: no data.
Intervention group 1+2 both involved psychoeducational involvement of families undertaken
by multidisciplinary team in clinics, 2 sessions of educational programme, 3 of
stress management, and 8 of goal setting. These groups added for this analysis. Groups
3+4 not split in data reporting and used as comparison for this analysis
*Only the 64 people fromhigh EE families were randomised to group 1+2 vs group 3+4,
and are used in this analysis. 19 from low EE families were allocated to groups 3+4 only
and are not included in this analysis
Allocation: ’randomly assigned’ - no further details.
Blindness: assessments blinded.
Duration: 18 months treatment, 18 months follow up.
Setting: Shashi & Jingzhou, China.
Diagnosis: schizophrenia (DSM-III-R).
N = 63*.
Age: range 17-54 years, mean 31.
Sex: 43 M, 20 F.
History: mean previous admissions ~ 4, mean duration ill ~ 7.5 years, participants living
with family
1. Family-educational supportive sessions (group and individual sessions: initially
monthly then sessions every 2-3 months. N = 34
2. Standard care: no clinic follow up + medication. N = 28.
Death.
Relapse.
Global state: GAF.
Mental state: BPRS-R, SAPS-CV, SANS-CV .
Hospital admission.
Drug compliance.
Family burden.
*One participant not accounted for.
Wrong outcomes
dublet
dublet
Wrong study design
Wrong outcomes
Wrong intervention
Wrong intervention
Wrong outcomes
Wrong outcomes
Wrong outcomes
Wrong outcomes
dublet
Wrong study design
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Randomised, computer generated
Randomised - no further details
Comment: Not described, only randomisation.
Randomised, no further details
Randomised using random numbers table
Randomised, no further details
Randomsied, by computer generation
Quote: "They were then selected randomly from the patient list, using a computer-generated random numbers table."
Quote: "the par- ticipants were randomly assigned to the usual care or the SCMP group."
Comment: Unclear how randomisation was doneIt only says "randomised"
Quote: "After completing the pre-test questionnaires after the outpatient clinic follow-up consultation, family caregivers were assigned into groups of three in terms of their patients’ dates of follow-up in the clinics and asked by the first author to draw a labelled card (one of three cards respectively labelled: 1 = ‘mutual support’; 2 = ‘psycho-education’;"
Comment: Patients primarily diagnosed as suffering from schizophreniawere selected randomly by the first author fromthe patient lists (in alphabetical order of their names) ofthe two outpatient clinics in Hong Kong.
Quote: "106 were randomly selected from the patient lists by means of computer-generated num- bers,"
no details
Randomised by pulling papers out of a hat
labelled with study group
No details
No details
Quote: "Randomisation was also stratified within each of the five participating centres and within in-patient or out-patient status at the time of relapse. Randomisation schedules were independently generated by a trial randomisation service"
Quote: "Carpenter, 1974). Two patients with level 0–1 or level 2–4 on the Quantity of Useful Work scale were randomized to two groups: family intervention+individual counselling+standard treat- ment, or individual counselling+standard treatment."
Comment: Not clear how randomisation was achieved?
No details
Randomised, no further details
No details
No details
Randomised, no further details
Comment: Unclear how randomisation was done
Quote: "Patients (and caregivers) were randomly allocated"
No details
No details
No details
No details
No details
No details
Randomised by block, no further details
Comment: unclear how
No details
No details
Randomised, no further details
Randomised, no further details
No details
No details
No details
Randomised, no further details
No details
No details
No details
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
No details
Randomised by a staff member who drew
names froma canister and,without looking
at the names
Comment: Not described
No details
No details
no details
Quote: "the participants were then asked by the principal researcher to draw a sealed opaque envelope,"
Comment: Not described.
no information
Comment: Not described
no details
No details
No details
Quote: "Randomisation schedules were independently generated by a trial randomisation service in a separate location from all trial centres (accessed by telephone),"
Comment: Randomisation schedules wereindependently generated by a trial randomisation service in aseparate location from all trial centres (accessed by telephone)
Quote: "1974). Two patients with level 0–1 or level 2–4 on the Quantity of Useful Work scale were randomized to two groups: family intervention+individual counselling+standard treat- ment, or individual counselling+standard treatment. The allocation to each group was carried out blind to the identity of the patient."
Comment: The allocation to each group was carried out blind tothe identity of the patient.
No details
No details
No details
No details
No details
No details
Comment: Nor described.
Comment: Patients (and caregivers) were randomly allocatedto the structured psychoeducational intervention,or the routine-care group, using a spss-basedcomputer program.
No details
No details
No details
No details
No details
No details
No details
No details
No details
Comment: Not described - probably not done
No details
No details
No details
No details
No details
No details
No details
No details
no details
No details
No details
No details
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Single, untested
Single blind, independent researchers who
were blind to study condition, untested
Comment: Not possible to blind pt' or personnel
Not blinded
no details
No details
no details
Quote: "Except for the principal researcher and the group instructor, all other clinic staffs were blinded to treatment allocation."
Comment: Patient ptobably not blinded
Comment: Not possible to blind patients, therapists or caregivers
Comment: Not possible to blind pt's or personel
Comment: Not possible
no details
open study
Comment: Not possible to blind pt's and personnel
Comment: Not possible to blid pt's and personnel
Single blind, untested
Not blinded
Comment: With the written consent of both patients and mothers, participants received the interventions on two different days of the week; they were therefore unaware of the other intervention methods.
Comment: Not possible
No details
No details
No details
No details
No details
Single, untested
Comment: Not possible.
No details
No details
No details
Open study
Single, untested
No details
Single blind, untested
No details
No details
Detection bias due to knowledge of the allocated interventions by outcome assessors
Single, untested
No details
Comment: Very little is descibed, but it says: The variables were assessedon a monthly basis and were blind with respect to treatment. Theassessment was made by a single psychiatrist who interviewed thepatients’ treating psychiatrists
No details
Follow-up assessments were carried out by
research assistants blind about the treatment
assigned, untested
No details
no details
Quote: "clinic staff and an outcome assessor who were blind to the families’ allocation of groups; (c)"
Comment: One researcher who was blind tothe group assignment administeredthe pretest before the patient-caregiver caregiverdyads were randomly assigned togroups and administered two posttestsat one and 15 months after theintervention.
Comment: Unclear if blinded
Quote: "Participants were assessed at recruitment and again one week (posttest 1), 18 months (posttest 2), and 36 months (posttest 3) after completion of the interventions by a trained research nurse who was independent from the participants’ recruitment procedure and blind to their intervention participation."
no details
No details
No details
Quote: "Trial research assessors were independent of treatment delivery and every effort was made to ensure they were kept masked to allocation. The primary outcome variable, relapse, was assessed by masked panel evaluation following the procedure"
Comment: Trial research assessors were independent of treatment deliveryand every effort was made to ensure they were kept masked toallocation. The primary outcome variable, relapse, was assessedby masked panel evaluation following the procedure describedby Craig et al1 and Bebbington et al
Quote: "Evaluation was carried out by a psychiatrist who was not involved in the processes of treatment, randomization or allocation. Active mea- sures were taken to guarantee the evaluator’s blind- ness to the patient study group."
No details
Single blind, untested
No details
Not blinded
Comment: Following intervention, an independent trained assessor undertook measurement
Quote: "This was a blind rating done by one consultant psychiatrist trained in the use of PANSS, based on information from the patient supplemented by the caregiver."
Comment: probably all assesments were blinded. First assesment also most important
No details
No details
No details
No details
No details
No details
No details
No details
Single, untested
Comment: Not described.
No details
No details
Open study
Single, untested
single blind
No details
No details
Single blind, untested
No details
No details
Attrition bias due to amount, nature or handling of incomplete outcome data
Study attrition reported
Study attrition reported
Comment: No incompleted participants:All patients completed the therapy prescribed for the12 months in question and were reassessed 12 monthsafter the course of treatment was completed.
Study attrition reported
Study attrition not reported
Study attrition reported
Comment: ITT analysis and only 1/35 and 2/35 repectively dropped out
Quote: "Data were an- alyzed on an intention-to-treat basis that maintained the advantages of ran- dom allocation"
Comment: High FU rates.
Quote: "All of the data were analysed on an intention-to- treat basis"
Comment: And only 1/45 and 2/45 dropout
Quote: "FPGP (very low dropout rates)."
no details
Quote: "An intention-to-treat analysis was performed."
Comment: And no dropoutHigh FU rates.
Study attrition reported
Study attrition reported
Comment: No ITT but relatively small and equal dropout (2/18 and 3/18)
Quote: "Results of the repeated measures manova were significant for both the Ôintent-to treatÕ sample and the ÔcompletersÕ sub- sample. This indicated that structured-intervention"
Comment: But dropout 39 %
No details
No details
Study attrition reported
Comment: Dropout not described. No itt analysis. but Intervenion relatively shortHigh FU rates.
Study attrition not reported
Study attrition reported
No details
Study attrition not reported
Reporting bias due to selective outcome reporting
No details
No details
Comment: No trial protocol.
No details
no details
No details
no details
Comment: No protocol but study well done
Quote: "ClinicalTrials.gov (NCT00940394)]"
Comment: Outcome in protocol relevant and assessed
Quote: "This trial is registered as NCT00940394 at clinicaltrials.gov."
Comment: Outcome from protocol reported
no details
Not all outcome data reported
No details
No details
Comment: No protocol but relevant outcome assessed
No details
No details
No details
No details
No details
No details
Comment: They write in the measurements section: The number and duration of psychiatric hospital admissions during the preceding three months at T1, T2 and T3 were obtained from the outpatient clinic records.They never present the results.No protocol
Comment: Table 4, much more reported for baseline, than end of treatment.No protocol
No details
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Quote: "Clinical"
Comment: Main outcome meassure - burden - reported in protocol
No details
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no details
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Bias due to problems not covered elsewhere in the table
No details
Principally funded by grant 1997-0219
from the Victorian Health Promotion
Foundation
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